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The medical terrain continues to change rapidly, and additional
overhauls are expected as the Affordable Care Act, accountable
care organizations, and other federal initiatives alter the landscape
further. To survive, every segment of healthcare will have to justify its
value, showing direct links to patient wellness; evidence-based medicine
(EBM)-loosely defined as medical practices that rely on modern best
evidence, clinical experience, and research studies-is being mandated for
each discipline. Accordingly, the O&P profession will need to conduct and
compile clear research and studies verifying the efficacy of its interventions.
An earlier article, "The Effectiveness of Foot Orthotics" (The O&P EDGE, July 2011,), outlined 25 scientific papers that demonstrate the benefits of using foot orthotics to treat a variety of conditions. This article builds on that evidence, presenting another 15 studies to further highlight the value of that type of intervention.
The knee is the largest joint in the
body and most people will experience
knee pain at some point in
their lifetimes. Pain can develop
as a result of overuse, a sudden
increase in activity, or a systemic
disease such as arthritis. One aspect
of knee pain that has been studied
closely is patellofemoral pain syndrome
(PFPS), which is generally
described as pain in the anterior
knee or around the patella region.
It is a complex subject with many
subtleties. Due to its prevalence,
researchers have closely studied
the kinematics of the knee and
lower leg to understand motion in
walking and running, seeking connections
between excessive movement
and pathology. Foot orthotics
can control foot pronation, ankle
motion, and tibial rotation, thereby
potentially relieving symptoms
associated with PFPS.
References: Knee Pain
- Saxena, A., and J. Haddad. 2003. The effect of foot orthoses on patellofemoral pain syndrome.
Journal of the American Podiatric Medical Association 93 (4):264-71.
This resource presents a retrospective review of 102 patients. At their follow-up visits, 76.5 percent were improved and 2 percent were asymptomatic, showing a significant decrease in the
level of pain with orthoses intervention. Although multiple treatment modalities were used for
these patients, the results suggest that the use of semiflexible orthoses is significant in reducing
symptoms of [knee pain].
- Johnston, L. B., and M. T. Gross. 2004. Effects of foot orthoses on quality of life for individuals
with patellofemoral pain syndrome. Journal of Orthopaedic and Sports Physical Therapy 34
Sixteen subjects with patellofemoral pain who also exhibited signs of excessive foot pronation
were studied. All Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
subscale scores were significantly improved at three months compared with pre-intervention
measurements. Conclusion: Custom-fitted foot orthoses may improve patellofemoral pain
symptoms for patients who demonstrate excessive foot pronation.
- Ferrari, R. 2014. A cohort-controlled trial of custom-made foot orthoses in anserine bursitis.
Journal of Prosthetics and Orthotics 26 (1):33-7.
The aim of this study was to determine the proportion of subjects (n = 69) reporting recovery
from anserine bursitis [medial knee pain] with prescribed custom-made foot orthoses in addition
to local corticosteroid injection versus injection alone.... The addition of custom-made foot
orthoses to local injection seems to improve the short- and long-term outcomes (88 percent of the
study group versus 41 percent of the control group reported recovery at four months) with fewer
Postural Control and Balance
Postural control is defined as
the act of maintaining, achieving,
or restoring a state of
balance during any posture or
activity. The effects of orthotics
on postural control have been
studied closely because elderly
patients with compromised
balance can pay a high price
when control is lost. Poor
balance has been associated
with a risk for falls, and the
Centers for Disease Control
and Prevention report that
one out of three people over
age 65 fall each year. Twenty
percent of cases in which an
elderly person trips result in
serious consequences, such as
a fracture or head injury.
References: Postural Control and Balance
- Cobb, S. C., L. L. Tis, and J. T. Johnson. 2006. The effect of 6 weeks of custom-molded foot orthosis
intervention on postural stability in participants with > or = 7 degrees of forefoot varus. Clinical Journal
of Sport Medicine 16 (4):316-22.
In this study, the authors conclude that six weeks of foot orthotic intervention may significantly improve
postural stability in subjects with > 7 degrees of forefoot varus both when wearing foot orthotics and
when not wearing foot orthotics. (Author's note: This indicates there may be a learned behavior component
associated with orthotic therapy.)
- Gross, M. T., V. S. Mercer, and F. C. Lin. 2012. Effects of foot orthoses on balance in older adults. Journal of Orthopaedic and Sports Physical Therapy 42 (7):649-57.
Thirteen individuals older than 65 years, who reported at least one unexplained fall during the past year
and demonstrated poor balance, participated in the study. The results provide preliminary evidence that
[custom] foot orthoses can effect improvement in balance measures for older adults.
- de Morais Barbosa, C., M. Barros Bértolo, J. F. Marques Neto, I. Bellini Coimbra, M. Davitt, and E. de Paiva
Magalhães. 2013. The effect of foot orthoses on balance, foot pain and disability in elderly women with
osteoporosis: A randomized clinical trial. Rheumatology (Oxford) 52 (3):515-22.
This study is an evaluation of the effect of insoles with medial arch support and metatarsal pad on balance,
foot pain, and disability in 94 elderly women with osteoporosis. Conclusion: Foot orthoses are effective
for improving balance and for reducing pain and disability in elderly women. Orthoses can be used as an
adjuvant strategy to improve balance and to prevent falls in the elderly.
Inversion Ankle Sprains in Active Adults
Another common injury
related to balance is the inversion
ankle sprain. Lateral
ankle sprains are among the
most common injury in sports
and account for a significant
percentage of total time lost
due to injuries. Research supports
the use of foot orthotics
for improving balance, a
key prevention component.
The aim is to provide range
of motion while engaging the
sensor systems on the plantar
foot, which allows sufficient
time for the body to react when
it senses sudden imbalance. Use
of an intrinsically balanced,
semirigid shell with a deep heel
cup seems to improve plantar
contact and give good mechanical
support without blocking
References: Inversion Ankle Sprain
- Orteza, L. C., W. D. Vogelbach, and C. R. Denegar. 1992. The effect of molded and unmolded orthotics on
balance and pain while jogging following inversion ankle sprain. Journal of Athletic Training 27 (1):80-4.
This study examined the effects of using molded orthotics on nine people who had suffered an inversion
ankle sprain. During each part of the study, the subjects were tested while they were using a molded
orthotic, an unmolded orthotic, and no orthotic in their shoes. Molded orthotics helped to decrease ankle
pain during jogging for those with an ankle sprain, but unmolded orthotics did not. These findings suggest
that molded orthotics may play a role in the treatment of inversion ankle sprains.
- Guskiewicz, K. M., and D. H. Perrin. 1996. Effect of orthotics on postural sway following inversion ankle
sprain. Journal of Orthopaedic and Sports Physical Therapy 23 (5):326-31.
Orthotic devices have been shown to successfully modify selected aspects of lower-extremity mechanics and enhance foot stability during the support phase of running.... Postural sway with orthotic intervention improved significantly more in injured subjects than in uninjured subjects. Analysis revealed that orthotic intervention significantly reduced postural sway when the platform moved in the medial/lateral plane and inversion/eversion plane. This research suggests that custom-fit orthotics may restrict undesirable motion at the foot and ankle and enhance joint mechanoreceptors to detect perturbations and provide structural support for detecting and controlling postural sway in ankle-injured subjects.
- Ochsendorf, D. T., C. G. Mattacola, and B. L. Arnold. 2000. Effect of orthotics on postural sway after fatigue of the plantarflexors and dorsiflexors. Journal of Athletic Training 35 (1):26-30.
This study examined the effects of orthotic intervention on unilateral postural sway after fatigue of the plantarflexor and dorsiflexor muscle groups. The results suggest that molded orthotics may be an effective means of decreasing postural sway after an isokinetic fatigue protocol. Further research is needed to determine the exact mechanism of this improvement and whether orthotics are an effective means of
preventing ankle injury.
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Plantar Fasciitis and Heel Pain
The American College of Foot
and Ankle Surgeons (ACFAS)
published its revised clinical
practice guidelines for heel pain
in 2010. The authors outline a
three-tier approach with initial
simple and cost-effective interventions
and more resistant
cases using more aggressive
treatment. Their document
states, "custom foot orthotics
should be considered after six
weeks only when other conservative
measures have not
References: Plantar Fasciitis and Heel Pain
- Turlik, M. A., T. J. Donatelli, and M. G. Veremis. 1999. A comparison of shoe inserts in relieving
mechanical heel pain. The Foot 9 (2):84-7.
This article represents a study of 60 patients to evaluate the effectiveness of generic heel pads and
functional foot orthotic devices in relieving symptoms of heel spur syndrome. Both groups of patients
demonstrated a reduction in duration and severity of symptoms post-treatment. Patients receiving
functional foot orthotic devices made from a standardized process obtained a better outcome on all
- Martin, J. E., J. C. Hosch, W. P. Goforth, R. T. Murff, D. M. Lynch, and R. D. Odom. 2001. Mechanical
treatment of plantar fasciitis. A prospective study. Journal of the American Podiatric Medical Association 91 (2):55-62.
A cohort of 255 subjects were randomly assigned to one of three treatment groups: custom-made orthoses,
over-the-counter arch supports, or tension night splints. No statistically significant difference was noted
among treatment groups with respect to final outcomes based on first-step pain or pain felt during the day.
However, there was a statistically significant difference among the three groups with respect to early patient
withdrawal from the study due to continued severe pain, noncompliance, or inability to tolerate the device.
Patient compliance was greatest with the use of custom-made orthoses.
- Rome, K., J. Gray, F. Steward, S. C. Hannant, D. Callaghan, and J. Hubble. 2004. Evaluating the clinical
effectiveness and cost-effectiveness of foot orthoses in the treatment of plantar heel pain: A feasibility
study. Journal of the American Podiatric Medical Association 94 (3):229-38.
Forty-eight patients were randomly assigned to receive either a functional or an accommodative orthosis.
The results demonstrated a significant decrease in foot pain and a significant increase in foot function with
the functional foot orthoses over the eight-week trial. The accommodative foot orthoses demonstrated
a significant reduction in foot pain only at four weeks. The cost-effectiveness analysis demonstrated that
functional orthoses, although initially more expensive, result in a better quality of life.
Both functional and accommodative
foot orthotics have been
used successfully to treat general
foot pain. This pain may be the
result of a systemic disease such
as rheumatoid arthritis or may
be related to foot mechanics. In
all cases, foot pain tends to limit
activity and patient quality of life
usually diminishes. Orthotics
can be an important component
of the treatment plan for patients
suffering from certain forms of
References: Foot Pain
- Burns, J., J. Crosbie, R. Ouvrier, and A. Hunt. 2006. Effective orthotic therapy for the painful cavus foot: A randomized controlled trial. Journal of the American Podiatric Medical Association 96 (3):205-11.
In a randomized, single-blind, sham-controlled trial, the effect of custom foot orthoses on foot pain, function, quality of life, and plantar pressure loading in people with a cavus foot type was investigated (n = 154). In conclusion, custom foot orthoses are more effective than a control for the treatment of cavus foot pain and its associated limitation in function.
- Ferrari, R. 2012. A cohort-controlled trial of the addition of customized foot orthotics to standard care in
fibromyalgia. Clinical Rheumatology 31 (7):1041-5.
A total of 67 consecutive patients presenting with chronic, widespread pain, who met the 1990 American
College of Rheumatology criteria for fibromyalgia, were included in the study. As part of a complex
intervention, in a cohort-controlled trial of primary care patients with fibromyalgia, the addition of custom-made
foot orthotics to usual care appears to improve functioning in the short term.
- Gatt, A., C. Formosa, and S. Otter. 2016. Foot orthoses in the management of chronic subtalar and
talocrural joint pain in rheumatoid arthritis. The Foot 27:27-31.
This pilot study investigated whether semirigid and soft orthoses had an effect on pain, disability,
and functional limitation in participants (n = 9) with chronic rheumatoid hindfoot involvement. Both
Subortholene™ and EVA orthoses significantly reduced pain, disability, and functional limitations in
participants with chronic ankle/subtalar joint pain in rheumatoid arthritis.
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Good research is methodical and precise,
sometimes revealing clear results and other
times clarifying the path for further investigation.
It yields answers regarding the devices
and care that we, as practitioners, provide
on a daily basis. In some of the cited studies,
orthotics worked with other modalities, not
as standalone therapies, and custom orthotics
were not always better than prefabricated
options. There also appear to be subgroups
within patient populations that, depending
on the diagnosis and other individual factors
(biomechanics, available range of motion, previous
history of injury, etc.), respond better to
custom foot orthotics. We need to continue
the research to isolate these subgroups, test
for efficacy, and develop the best treatment
algorithms. It benefits our profession and our
patients when we advance the science through
Séamus Kennedy, BEng (Mech), CPed, is president and co-owner
of Hersco Ortho Labs, New York. He can be contacted via
e-mail at firstname.lastname@example.org or by visiting www.hersco.com.